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Change Control

Software for change control assures compliance and enhances productivity

In FDA-regulated and ISO environments, companies are expected to establish detailed procedures for change control (or change management) to assure product quality and safety. To meet this requirement, the change form must be able to collect all the information needed throughout the change management process.

Given the multitude of processes for document change that affect design specs, formulations, raw materials, SOPs, etc., change management software for change control is indispensable.

Aligning Business Practices with MasterControl Change Control Software

The modern trend of incorporating software solutions into existing business systems has addressed the basic needs of implementing changes in the majority of businesses. Paper-based or legacy systems lack the infrastructure to accommodate changes to most organizations' existing standard operating procedures (SOPs) and processes. The implementation of change is ideally managed from the initial planning stages. For this reason, successful companies approach a concept of change control that ensures all changes made to SOPs are properly documented without any unnecessary disruption of services.

To ensure that the change control process is systemized, it must be properly managed. This also guarantees that no uncalled for changes are made and that resources are properly and effectively utilized. A change control process is usually a result of a change request. A well thought out change in a process results in a series of steps that are then implemented in changes pertaining to software applications and hardware functions/upgrades as well business policies. MasterControl change control software allows for effective planning, execution, and implementation that best fits your company's needs.

MasterControl Provides Best Practice Change Control Forms

MasterControl change control software is a web-based platform that guarantees communication between different users, vendors, stakeholders, and employees through secure login accounts. As already mentioned, a change is usually triggered by filling out a change request form that enlists the reason, area, and initiator of the change. A change can be trigged through various sources. It is of extreme importance to correctly store these forms and ensure that the data entered in these forms is correctly entered in the system for further processing.

This is why the MasterControl change control software solution provides pre-configured, multi-page best practice forms for collecting and tracking data during the change control process. These best practice forms can be used as is or customized to meet the needs of the organization. The MasterControl change control process is divided in several stages including submission, evaluation, approval/ rejection, implementation, verification, possible validation, and close of project. The change control submission portion of the process includes a separate section that captures information such as description of change, justification, and impact. For an easy comparison, users can view both original and revised documents. Filling out many forms for multiple changes can be a tedious and overwhelming task, which is why MasterControl change control software allows users to fill out a single form with multiple change requests. Users can also attach additional relevant files to the form, which also streamlines the overall change control process and enhances traceability.

MasterControl Change Control Administers Comprehensive Changes throughout the Enterprise

With MasterControl, a change can be evaluated to determine its impact and importance within the system. Some changes are considered very critical and must be urgently incorporated in the business' processes while some may be considered to only be implemented at a low priority. It is also important to validate the change so that it easily passes any regulatory tests without any hassle.

The forms within the change control process can be made interdependent on each other. For example, a change submission form can be launched directly from a Corrective Action /Preventive Action (CAPA) form that also connects one process to the next. MasterControl also includes links that allow users to easily view what triggered the change. MasterControl also eliminates redundant data entry. For instance: all relevant information from the CAPA form can be automatically entered into a change submission form. In addition to this, the change control software system shows the history of the entire process.

Lastly, the documents linked with change submission forms can be approved all at once. Instead of going through the complete document approval cycle, administrators can link an updated document along with the implementation of the change, taking care of document approval without any delay.

The QMS Provider for the FDA

MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.